Imidapril Dari Pharma 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Imidapril Dari Pharma 10 mg tablets EFG

Imidapril hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Imidapril Dari Pharma is and what it is used for
2. What you need to know before taking Imidapril Dari Pharma
3. How to take Imidapril Dari Pharma
4. Possible side effects
5. How to store Imidapril Dari Pharma
6. Contents of the pack and other information

1. What Imidapril Dari Pharma is and what it is used for

Imidapril Dari Pharma belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).

Imidapril Dari Pharma is indicated for the treatment of high blood pressure (hypertension).

If you have high blood pressure, Imidapril Dari Pharma will work by dilating your blood vessels, allowing blood to flow more easily. Since blood pressure depends on the diameter of the blood vessels, your blood pressure will decrease with the help of Imidapril Dari Pharma. It will also be easier for your heart to pump blood through the vessels to the entire body.

2. What you need to know before taking Imidapril Dari Pharma

Do not take Imidapril Dari Pharma

• If you are allergic to imidapril, to other ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had angioedema (a severe allergic reaction characterized by swelling of the hands, feet or ankles, face, lips, tongue, and throat, which may lead to difficulty swallowing or breathing) after taking a medicine similar to imidapril (an ACE inhibitor).
• If you or a close family member has ever experienced angioedema.
• If you have any kidney disease or require dialysis.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant (Imidapril Dari Pharma should also be avoided at the beginning of pregnancy – see section Pregnancy).

Do not take Imidapril Dari Pharma if you are in any of the situations listed above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Imidapril Dari Pharma if:

• You are dehydrated due to treatment with diuretics (medicines to increase urine output), dialysis, a low-salt diet, or because you have had severe and prolonged vomiting or diarrhea. You may be at higher risk of a significant drop in blood pressure (hypotension) when starting the tablets, which could cause dizziness or fainting.

• You have been diagnosed with heart problems. Consult your doctor if you think you may have them.

• You have liver problems.

• You are diabetic.

• You are taking potassium supplements or potassium-containing salt substitutes.

• You are taking allopurinol to prevent gout, kidney stones, or high uric acid levels.

• You are taking procainamide to correct irregular heartbeats or to slow a rapid heartbeat.

• You are taking a medicine containing lithium, used to treat mania or depression.

• You are allergic to insect stings and are undergoing desensitization therapy.

• You are receiving any treatment affecting your immune system, for example after an organ transplant.

• You have recently undergone a kidney transplant.

• You are undergoing a treatment called "LDL apheresis" to reduce cholesterol levels in the blood.

• You have a condition known as "cerebrovascular disease" (narrowing of blood vessels in the brain).

• You have a disease known as "collagen vascular disease", such as rheumatoid arthritis.

• You are scheduled for surgery or will receive anesthesia – inform your doctor or dentist.

• Your blood pressure is not adequately controlled. This type of medicine appears to be less effective in people of Black origin.

• You experience sudden swelling of the lips and face, tongue and throat, neck, and possibly also the hands and feet, difficulty swallowing and breathing, hives, or hoarseness ("angioedema"). This may occur at any time during treatment. People of Black origin may have a higher risk of this reaction. If you develop these symptoms, inform your doctor immediately.

• You are taking any of the following medicines for high blood pressure (hypertension):

  O An angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

  O Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Imidapril Dari Pharma”.

If you are pregnant (or suspect you might be), inform your doctor. The use of Imidapril Dari Pharma is not recommended at the beginning of pregnancy and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby (see section Pregnancy).

Children and adolescents

The use of Imidapril Dari Pharma tablets is not recommended in children.

While taking Imidapril Dari Pharma

If you develop any of the following symptoms, inform your doctor immediately:

• If you feel lightheaded after the first dose. Some people react to the first dose or when the dose is increased, experiencing dizziness, weakness, fainting, or nausea.
• High temperature, sore throat, or mouth ulcers (these may be signs of infection due to a decrease in white blood cells).
• Yellowing of the skin and eyes (jaundice), which may be a sign of liver disease.

Regular medical check-ups will be necessary while you are taking Imidapril Dari Pharma, including regular blood tests. Close monitoring will be carried out when treatment is started or if the dose is changed. Your doctor will advise you on how often you need to attend follow-up visits.

Other medicines and Imidapril Dari Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor may need to adjust your dose and/or take additional precautions:

If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Imidapril Dari Pharma” and “Warnings and precautions”).

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant, before using this medicine. Your doctor will usually advise you to stop taking Imidapril Dari Pharma before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive treatment. Imidapril Dari Pharma is not recommended during early pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your unborn baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Imidapril Dari Pharma is not recommended for women during lactation. Your doctor may decide to prescribe a more suitable treatment if you intend to breastfeed, especially if the infant is newborn or premature.

Driving and use of machines

Imidapril Dari Pharma may cause dizziness or drowsiness.

Refrain from driving or operating machinery until you know how Imidapril Dari Pharma affects you.

Imidapril Dari Pharma contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Imidapril Dari Pharma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

• Take the tablets approximately 15 minutes before meals
• Swallow the tablets with plenty of water
• Take the tablets at the same time each day
• The tablet may be divided into equal doses

The recommended dose is:

Adults

The usual initial dose is 5 mg once daily. After 3 weeks, your blood pressure should be measured again to assess the response. Your doctor may increase the daily dose to 10 mg or up to 20 mg.

Your doctor may advise starting with 2.5 mg daily

• if you have mild kidney or liver problems
• if you have heart problems, chest pain, cerebrovascular disorders, low levels of salt and/or fluids, or
• if there is a risk that your blood pressure might drop suddenly

Patients aged 65 years and older

Your doctor will start treatment with 2.5 mg once daily and may increase the dose up to 10 mg, depending on your response to treatment.

Use in children

The use of Imidapril Dari Pharma tablets is not recommended in children.

If you take more Imidapril Dari Pharma than you should

If you have accidentally taken more tablets than prescribed, contact your doctor immediately. Remember to bring any leftover tablets and the packaging with you. The most common signs and symptoms of overdose include low blood pressure, shock, and stupor (a state of near-complete loss of consciousness), slowed heart rate, disturbances in potassium or other electrolyte levels, and kidney failure. This may result in a general feeling of being unwell, awareness of your heartbeat (palpitations), or swelling of the fingers, legs, and toes (edema).

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91.562.04.20 immediately, stating the name of the medicine and the amount ingested.

If you forget to take Imidapril Dari Pharma

Do not take a double dose to make up for a missed dose. Do not take the missed dose; instead, skip it and continue with your regular dosing schedule at the usual time.

If you stop taking Imidapril Dari Pharma

Do not stop taking Imidapril Dari Pharma unless your doctor advises you to do so. If you stop taking this medicine, your blood pressure may rise. If your blood pressure becomes too high, it may affect the function of your heart and kidneys.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

It is very important that you contact your doctor immediately and stop taking Imidapril Dari Pharma if you develop any of the following symptoms:

• headache, dizziness, lightheadedness, possibly accompanied by vision disturbances. This is particularly important when starting treatment or when the dose is increased
• difficulty breathing
• rash or itching
• a severe allergic reaction causing swelling of the face or throat (angioedema), blisters on the skin, mouth, eyes, and genital organs (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• yellowing of the skin and eyes due to liver or blood problems (jaundice)

Inform your doctor or pharmacist if you experience any of the following adverse effects:

Common adverse effects (may affect up to 1 in 10 people)

• fatigue/sleepiness
• cough
• feeling sick (nausea)

Uncommon adverse effects (may affect up to 1 in 100 people)

• awareness of your own heartbeat (palpitations)
• narrowing of blood vessels in the brain (cerebrovascular disease)
• feeling faint
• tingling or numbness in the hands or feet
• swelling and irritation inside the nose
• vomiting
• pain in the upper abdomen
• indigestion (stomach discomfort)
• bronchitis
• viral infection
• upper respiratory tract infection
• chest pain
• limb pain
• swelling of fingers, legs, and toes (edema)

Rare adverse effects (may affect up to 1 in 1,000 people)

• reduction (decrease in number) of white blood cells, making infections more likely
• reduction (decrease in number) of red blood cells, which may cause paleness of the skin, weakness, and shortness of breath

Effects on blood test results

Imidapril Dari Pharma may cause changes in blood composition. Your doctor will carry out regular blood tests and explain the results to you.

The following adverse effects have been reported with this type of medicine:

• blurred vision
• balance disorders; confusion; ringing in the ears
• tiredness; depression; sleep disturbances; impotence
• taste disturbances
• changes in heart rhythm (faster, irregular); heart attack; transient ischemic symptoms
• increased risk of bleeding or bruising
• hives; skin redness
• hair loss
• shortness of breath; wheezing
• inflammations – for example, of the nasal cavities (sinusitis), tongue (glossitis), liver (hepatitis), pancreas (pancreatitis), or stomach lining (gastritis)
• diarrhea; constipation; dry mouth
• intestinal obstruction; inflammation of the intestines causing colic
• kidney problems
• fever
• muscle pain; joint pain

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Imidapril Dari Pharma

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original container.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Imidapril Dari Pharma

• The active substance is imidapril hydrochloride. Each tablet contains 10 mg of imidapril hydrochloride.
• The other components are: anhydrous calcium hydrogen phosphate, pregelatinized corn starch, lactose monohydrate, sodium croscarmellose (E 468) and glycerol dibehenate.

Appearance of the product and contents of the pack

Imidapril Dari Pharma tablets are white, oblong-shaped, with the imprint “K2” on one side and scored on both sides.

The medicine is available in aluminum/aluminum blisters, in packs containing 14, 28 and 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona) - Spain

Date of the most recent revision of this leaflet: June 2021

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/